Bioventus
Senior Regulatory Specialist
Bioventus, Durham, North Carolina, United States, 27703
Are you ready to work for a more active world?
At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
The Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. The Sr Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures. (This role is hybrid.) What you'll be doingAuthor and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.Author and maintain Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development.Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies.Participate on cross-functional teams for projects as assigned.Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.Research requirements and set priorities while maintaining project schedules.Provide guidance and oversight to team members related to regulatory compliance.Reviewing marketing literature for compliance with applicable regulations and company policies and procedures.Execute additional responsibilities as defined by management.What you bring to the table
Bachelor's Degree in Life Sciences, Engineering or other related discipline.5 years of experience in Regulatory Affairs, preferably in the medical device industry.FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience.Ability to develop clear, concise, and timely oral and written communication and reports.Excellent communication skills, oral and written, with all levels of personnel.Must be detail oriented and possess considerable organizational skills.Experience with electromechanical and implantable medical devices and human tissue regulations is desirable.Ability to effectively partner with employees, management, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company.
Are you the top talent we are looking for?
Apply now! Hit the "Apply" button to send us your resume and cover letter.
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.
At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.
The Senior Regulatory Affairs Specialist provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements and authoring submissions. The Sr Regulatory Affairs Specialist is the Subject Matter Expert during external regulatory audits. Responsibilities include compliance with applicable regulations, standards and established corporate policies and procedures. (This role is hybrid.) What you'll be doingAuthor and submit applications 510(k), PMA Supplements and, Technical Documentation to receive product clearance / approvals for new products and maintain existing registrations globally.Author and maintain Technical Files compliant to the MDD 93/42/EEC and Technical Documentation compliant to the EU MDR 2017/745.Communicate with Regulatory Agencies regarding submissions, and changes of products, including manufacturing, design and new product development.Subject Matter Expert to represent Regulatory during internal audits and external audits by regulatory agencies.Participate on cross-functional teams for projects as assigned.Review protocols and reports for scientific validity and compliance to regulatory standards and provide scientific judgement to guide cross functional teams.Perform Regulatory Assessments for design, manufacturing, and labeling changes to ensure compliance with regulations and standards where the product is registered.Research requirements and set priorities while maintaining project schedules.Provide guidance and oversight to team members related to regulatory compliance.Reviewing marketing literature for compliance with applicable regulations and company policies and procedures.Execute additional responsibilities as defined by management.What you bring to the table
Bachelor's Degree in Life Sciences, Engineering or other related discipline.5 years of experience in Regulatory Affairs, preferably in the medical device industry.FDA, EU, Health Canada, Brazil, Japan, and Australia registration experience.Ability to develop clear, concise, and timely oral and written communication and reports.Excellent communication skills, oral and written, with all levels of personnel.Must be detail oriented and possess considerable organizational skills.Experience with electromechanical and implantable medical devices and human tissue regulations is desirable.Ability to effectively partner with employees, management, department, and cross-functional teams to meet performance objectives and to support mission and vision of the Company.
Are you the top talent we are looking for?
Apply now! Hit the "Apply" button to send us your resume and cover letter.
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.